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ABL Kinase Domain Mutation in CML, Cell-based
Test CodeABLKIN
Alias/See Also
16029
CPT Codes
81170
Preferred Specimen
5 mL whole blood collected in an EDTA (lavender-top) tube or 3 mL Bone marrow aspirate in an EDTA (lavender-top) tube
Minimum Volume
1 mL bone marrow • 3 mL whole blood
Other Acceptable Specimens
Bone marrow collected in a sodium heparin (green-top) tube • Whole blood collected in a sodium heparin (green-top) or ACD solution B (yellow-top) tube
Instructions
Do not reject specimens, send to laboratory for screening.
After collection of the sample, draw date and time, as well as sample type, must be written on the tube and included as requested information. Ship sample immediately due to short sample stability of 72 hours.
If the stability of the sample cannot be determined, delay in result or cancellation of test may occur.
After collection of the sample, draw date and time, as well as sample type, must be written on the tube and included as requested information. Ship sample immediately due to short sample stability of 72 hours.
If the stability of the sample cannot be determined, delay in result or cancellation of test may occur.
Transport Temperature
Refrigerated (cold packs)
Specimen Stability
Room temperature: 72 hours
Refrigerated: 72 hours
Frozen: Unacceptable
Methodology
Nested Polymerase Chain Reaction • Real-Time Polymerase Chain Reaction • Sequencing
FDA Status
This test was developed and its analytical performance characteristics have been determined by Quest Diagnostics. It has not been cleared or approved by FDA. This assay has been validated pursuant to the CLIA regulations and is used for clinical purposes.
Setup Schedule
Set up: Daily; Report available: 3-5 days
Reference Range
See Laboratory Report
Clinical Significance
IMATINIB mesylate (ST1571;GLEEVEC) is a selective BCR-ABL kinase inhibitor, effective in the treatment of chronic Myelogenous Leukemia (CML). Most patients in chronic phase maintain durable responses; however, many in blast crisis fail to respond, or relapse quickly. ABL kinase domain mutations are the most commonly identified mechanism associated with relapse. The molecular monitoring in the first few months of therapy may play a crucial role in detecting patients at high risk of IMATINIB resistance. This ABL kinase mutation assay may detect drug-resistant mutations before clinical relapse and identify candidate suitable for alternative therapy.
Performing Laboratory
Quest Diagnostics Nichols Institute
33608 Ortega Highway
San Juan Capistrano, CA 92690-6130
Last Updated: May 16, 2024
